Cargando…
Head-to-Head Comparison of Rapid and Automated Antigen Detection Tests for the Diagnosis of SARS-CoV-2 Infection
(1) Background: The detection of SARS-CoV-2 RNA in nasopharyngeal samples through real-time reverse transcription-polymerase chain reaction (RT-PCR) is considered the standard gold method for the diagnosis of SARS-CoV-2 infection. Antigen detection (AD) tests are more rapid, less laborious, and less...
Autores principales: | , , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2021
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7828347/ https://www.ncbi.nlm.nih.gov/pubmed/33450853 http://dx.doi.org/10.3390/jcm10020265 |
_version_ | 1783640989845422080 |
---|---|
author | Favresse, Julien Gillot, Constant Oliveira, Maxime Cadrobbi, Julie Elsen, Marc Eucher, Christine Laffineur, Kim Rosseels, Catherine Van Eeckhoudt, Sandrine Nicolas, Jean-Baptiste Morimont, Laure Dogné, Jean-Michel Douxfils, Jonathan |
author_facet | Favresse, Julien Gillot, Constant Oliveira, Maxime Cadrobbi, Julie Elsen, Marc Eucher, Christine Laffineur, Kim Rosseels, Catherine Van Eeckhoudt, Sandrine Nicolas, Jean-Baptiste Morimont, Laure Dogné, Jean-Michel Douxfils, Jonathan |
author_sort | Favresse, Julien |
collection | PubMed |
description | (1) Background: The detection of SARS-CoV-2 RNA in nasopharyngeal samples through real-time reverse transcription-polymerase chain reaction (RT-PCR) is considered the standard gold method for the diagnosis of SARS-CoV-2 infection. Antigen detection (AD) tests are more rapid, less laborious, and less expensive alternatives but still require clinical validation. (2) Methods: This study compared the clinical performance of five AD tests, including four rapid AD (RAD) tests (biotical, Panbio, Healgen, and Roche) and one automated AD test (VITROS). For that purpose, 118 (62.8%) symptomatic patients and 70 (37.2%) asymptomatic subjects were tested, and results were compared to RT-PCR. (3) Results: The performance of the RAD tests was modest and allowed us to identify RT-PCR positive patients with higher viral loads. For Ct values ≤25, the sensitivity ranged from 93.1% (95% CI: 83.3–98.1%) to 96.6% (95% CI: 88.1–99.6%), meaning that some samples with high viral loads were missed. Considering the Ct value proposed by the CDC for contagiousness (i.e., Ct values ≤33) sensitivities ranged from 76.2% (95% CI: 65.4–85.1%) to 88.8% (95% CI: 79.7–94.7%) while the specificity ranged from 96.3% (95% CI: 90.8–99.0%) to 99.1% (95% CI: 95.0–100%). The VITROS automated assay showed a 100% (95% CI: 95.5–100%) sensitivity for Ct values ≤33, and had a specificity of 100% (95% CI: 96.6–100%); (4) Conclusions: Compared to RAD tests, the VITROS assay fully aligned with RT-PCR for Ct values up to 33, which might allow a faster, easier and cheaper identification of SARS-CoV-2 contagious patients. |
format | Online Article Text |
id | pubmed-7828347 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-78283472021-01-25 Head-to-Head Comparison of Rapid and Automated Antigen Detection Tests for the Diagnosis of SARS-CoV-2 Infection Favresse, Julien Gillot, Constant Oliveira, Maxime Cadrobbi, Julie Elsen, Marc Eucher, Christine Laffineur, Kim Rosseels, Catherine Van Eeckhoudt, Sandrine Nicolas, Jean-Baptiste Morimont, Laure Dogné, Jean-Michel Douxfils, Jonathan J Clin Med Article (1) Background: The detection of SARS-CoV-2 RNA in nasopharyngeal samples through real-time reverse transcription-polymerase chain reaction (RT-PCR) is considered the standard gold method for the diagnosis of SARS-CoV-2 infection. Antigen detection (AD) tests are more rapid, less laborious, and less expensive alternatives but still require clinical validation. (2) Methods: This study compared the clinical performance of five AD tests, including four rapid AD (RAD) tests (biotical, Panbio, Healgen, and Roche) and one automated AD test (VITROS). For that purpose, 118 (62.8%) symptomatic patients and 70 (37.2%) asymptomatic subjects were tested, and results were compared to RT-PCR. (3) Results: The performance of the RAD tests was modest and allowed us to identify RT-PCR positive patients with higher viral loads. For Ct values ≤25, the sensitivity ranged from 93.1% (95% CI: 83.3–98.1%) to 96.6% (95% CI: 88.1–99.6%), meaning that some samples with high viral loads were missed. Considering the Ct value proposed by the CDC for contagiousness (i.e., Ct values ≤33) sensitivities ranged from 76.2% (95% CI: 65.4–85.1%) to 88.8% (95% CI: 79.7–94.7%) while the specificity ranged from 96.3% (95% CI: 90.8–99.0%) to 99.1% (95% CI: 95.0–100%). The VITROS automated assay showed a 100% (95% CI: 95.5–100%) sensitivity for Ct values ≤33, and had a specificity of 100% (95% CI: 96.6–100%); (4) Conclusions: Compared to RAD tests, the VITROS assay fully aligned with RT-PCR for Ct values up to 33, which might allow a faster, easier and cheaper identification of SARS-CoV-2 contagious patients. MDPI 2021-01-13 /pmc/articles/PMC7828347/ /pubmed/33450853 http://dx.doi.org/10.3390/jcm10020265 Text en © 2021 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Article Favresse, Julien Gillot, Constant Oliveira, Maxime Cadrobbi, Julie Elsen, Marc Eucher, Christine Laffineur, Kim Rosseels, Catherine Van Eeckhoudt, Sandrine Nicolas, Jean-Baptiste Morimont, Laure Dogné, Jean-Michel Douxfils, Jonathan Head-to-Head Comparison of Rapid and Automated Antigen Detection Tests for the Diagnosis of SARS-CoV-2 Infection |
title | Head-to-Head Comparison of Rapid and Automated Antigen Detection Tests for the Diagnosis of SARS-CoV-2 Infection |
title_full | Head-to-Head Comparison of Rapid and Automated Antigen Detection Tests for the Diagnosis of SARS-CoV-2 Infection |
title_fullStr | Head-to-Head Comparison of Rapid and Automated Antigen Detection Tests for the Diagnosis of SARS-CoV-2 Infection |
title_full_unstemmed | Head-to-Head Comparison of Rapid and Automated Antigen Detection Tests for the Diagnosis of SARS-CoV-2 Infection |
title_short | Head-to-Head Comparison of Rapid and Automated Antigen Detection Tests for the Diagnosis of SARS-CoV-2 Infection |
title_sort | head-to-head comparison of rapid and automated antigen detection tests for the diagnosis of sars-cov-2 infection |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7828347/ https://www.ncbi.nlm.nih.gov/pubmed/33450853 http://dx.doi.org/10.3390/jcm10020265 |
work_keys_str_mv | AT favressejulien headtoheadcomparisonofrapidandautomatedantigendetectiontestsforthediagnosisofsarscov2infection AT gillotconstant headtoheadcomparisonofrapidandautomatedantigendetectiontestsforthediagnosisofsarscov2infection AT oliveiramaxime headtoheadcomparisonofrapidandautomatedantigendetectiontestsforthediagnosisofsarscov2infection AT cadrobbijulie headtoheadcomparisonofrapidandautomatedantigendetectiontestsforthediagnosisofsarscov2infection AT elsenmarc headtoheadcomparisonofrapidandautomatedantigendetectiontestsforthediagnosisofsarscov2infection AT eucherchristine headtoheadcomparisonofrapidandautomatedantigendetectiontestsforthediagnosisofsarscov2infection AT laffineurkim headtoheadcomparisonofrapidandautomatedantigendetectiontestsforthediagnosisofsarscov2infection AT rosseelscatherine headtoheadcomparisonofrapidandautomatedantigendetectiontestsforthediagnosisofsarscov2infection AT vaneeckhoudtsandrine headtoheadcomparisonofrapidandautomatedantigendetectiontestsforthediagnosisofsarscov2infection AT nicolasjeanbaptiste headtoheadcomparisonofrapidandautomatedantigendetectiontestsforthediagnosisofsarscov2infection AT morimontlaure headtoheadcomparisonofrapidandautomatedantigendetectiontestsforthediagnosisofsarscov2infection AT dognejeanmichel headtoheadcomparisonofrapidandautomatedantigendetectiontestsforthediagnosisofsarscov2infection AT douxfilsjonathan headtoheadcomparisonofrapidandautomatedantigendetectiontestsforthediagnosisofsarscov2infection |